The Hulk trial is designed to evaluate the safety and efficacy of a suprachoroidal injection of its suspension formulation of a corticosteroid, triamcinolone acetonide, with and without an intravitreal injection of Eylea in DME patients. The Alpharetta, Ga.-based company said it expects preliminary results from the study in the 2nd half of this year.
“While the current standard of care in treating patients with DME is through the use of intravitreally delivered anti-VEGF agents, a significant unmet need remains in this large patient population. Approximately 40% of DME patients have an insufficient response to VEGF inhibitors. We believe that, by administering suprachoroidal CLS-TA with the potential to access the retina and choroid in high amount, concomitantly with intravitreal Eylea, there is the opportunity to more effectively treat DME when compared with current intravitreal anti-VEGF or corticosteroid therapies used alone,” president & CEO Daniel White said in prepared remarks. “I would like to take this opportunity to thank the participating physicians and patients in the HULK trial, and to congratulate our team for working so diligently and effectively to complete study enrollment with the goal of addressing the needs of these patients. We are also in the process of final preparations to initiate a larger Phase 2 trial in this blinding eye disease.”
Clearside also said it is slated to enroll the 1st patient in a Phase II trial in mid-2017. The company plans to evaluate suprachoroidal CLS-TA with intravitreal Eylea compared to Eylea alone in patients with DME over a 6-month study period. The study’s primary endpoint will be the change in best corrected visual acuity, Clearside said.